Alprazolam Extended Release Oral Tablet

Brand(s)
Xanax
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pharmacia And Upjohn Company (2013-10-01)
Oldest Current Product
2003-01-17
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
EXTENDED RELEASE ORAL TABLET\ALPRAZOLAM
FDAOB
ORAL\TABLET, EXTENDED RELEASE\ALPRAZOLAM
SPL Active
ORAL\TABLET, EXTENDED RELEASE\ALPRAZOLAM
SPL Moiety
ORAL\TABLET, EXTENDED RELEASE\ALPRAZOLAM

product(s) by strength(s)

24 hr alprazolam 0.5 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000090057XanaxNDAPharmacia And Upjohn Company2003-01-17ALPRAZOLAMORALTABLET, EXTENDED RELEASENDA021434aa58fff3-c297-49be-838b-599c32ad9835

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001158311ANDAGlobal Pharmaceuticals2007-05-24ALPRAZOLAMORALTABLET, EXTENDED RELEASEANDA07796850710e43-bb70-4a2c-a95c-803c3302370d
2002283083ANDAActavis Elizabeth Llc2007-02-13ALPRAZOLAMORALTABLET, EXTENDED RELEASEANDA078056a64496be-bf43-4ba9-a4b1-bd632965c1a0
3003785021ANDAMylan Pharmaceuticals Inc.2006-01-26ALPRAZOLAMORALTABLET, EXTENDED RELEASEANDA077391d6cbcdd1-ef4e-487f-83a5-176789b449f5
4597620057NDA AUTHORIZED GENERICGreenstone Llc2003-01-17ALPRAZOLAMORALTABLET, EXTENDED RELEASENDA0214341338d1c9-7c75-42ed-95f3-9eb1b6fc51d3
5605052634ANDAApotex Corp2008-11-12ALPRAZOLAMORALTABLET, EXTENDED RELEASEANDA078449b244cda0-27f1-6708-c5df-916e7b53bd99
6647200187ANDACorepharma, Llc2007-03-28ALPRAZOLAMORALTABLET, EXTENDED RELEASEANDA0779964440015d-5a5c-4f2e-8993-13a94035d70a
7651620809ANDAAmneal Pharmaceuticals2009-12-03ALPRAZOLAMORALTABLET, EXTENDED RELEASEANDA078387259387c1-e374-4bc2-9510-5f7f2c60d1a5
8658620454ANDAAurobindo Pharma Limited2011-06-07ALPRAZOLAMORALTABLET, EXTENDED RELEASEANDA090871326fa31a-5420-429b-9f7f-170cb38f64bd

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950602ANDARebel Distributors Corp2009-12-03ALPRAZOLAMORALTABLET, EXTENDED RELEASE651620809ANDA07838798cc444a-2c39-4410-8020-aded0a8deb81
2557000109NDA AUTHORIZED GENERICLake Erie Medical Dba Quality Care Products Llc2003-01-17ALPRAZOLAMORALTABLET, EXTENDED RELEASE597620057NDA02143479114030-6131-4516-9657-a74058dfb87a
3631870337ANDAProficient Rx Lp2006-01-26ALPRAZOLAMORALTABLET, EXTENDED RELEASE003785021ANDA07739131dacbaf-4245-4172-9da4-514be309f341
4631870518ANDAProficient Rx Lp2011-06-07ALPRAZOLAMORALTABLET, EXTENDED RELEASE658620454ANDA090871969acb29-3b5c-47ed-8f7d-a960a24e72e3
5636291541ANDABryant Ranch Prepack2007-03-28ALPRAZOLAMORALTABLET, EXTENDED RELEASE649800140ANDA0779965c921bf0-0a5a-4408-a3d7-b02f907aa321
6636294061ANDABryant Ranch Prepack2007-03-28ALPRAZOLAMORALTABLET, EXTENDED RELEASE649800140ANDA0779963292a8ff-0664-c0a4-42a6-9827ddb93665
7636295364ANDABryant Ranch Prepack2007-02-13ALPRAZOLAMORALTABLET, EXTENDED RELEASE002283083ANDA0780567e96bc50-4985-4c19-8be9-4f4cf7184c64

24 hr alprazolam 1 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000090059XanaxNDAPharmacia And Upjohn Company2003-01-17ALPRAZOLAMORALTABLET, EXTENDED RELEASENDA021434aa58fff3-c297-49be-838b-599c32ad9835

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001158322ANDAGlobal Pharmaceuticals2007-05-24ALPRAZOLAMORALTABLET, EXTENDED RELEASEANDA07796850710e43-bb70-4a2c-a95c-803c3302370d
2002283084ANDAActavis Elizabeth Llc2007-02-13ALPRAZOLAMORALTABLET, EXTENDED RELEASEANDA078056a64496be-bf43-4ba9-a4b1-bd632965c1a0
3003785022ANDAMylan Pharmaceuticals Inc.2006-01-26ALPRAZOLAMORALTABLET, EXTENDED RELEASEANDA077391d6cbcdd1-ef4e-487f-83a5-176789b449f5
4597620059NDA AUTHORIZED GENERICGreenstone Llc2003-01-17ALPRAZOLAMORALTABLET, EXTENDED RELEASENDA0214341338d1c9-7c75-42ed-95f3-9eb1b6fc51d3
5605052635ANDAApotex Corp2008-11-12ALPRAZOLAMORALTABLET, EXTENDED RELEASEANDA078449b244cda0-27f1-6708-c5df-916e7b53bd99
6647200188ANDACorepharma, Llc2007-03-28ALPRAZOLAMORALTABLET, EXTENDED RELEASEANDA0779964440015d-5a5c-4f2e-8993-13a94035d70a
7651620810ANDAAmneal Pharmaceuticals2009-12-03ALPRAZOLAMORALTABLET, EXTENDED RELEASEANDA078387259387c1-e374-4bc2-9510-5f7f2c60d1a5
8658620455ANDAAurobindo Pharma Limited2011-06-07ALPRAZOLAMORALTABLET, EXTENDED RELEASEANDA090871326fa31a-5420-429b-9f7f-170cb38f64bd

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950603ANDARebel Distributors Corp2009-12-03ALPRAZOLAMORALTABLET, EXTENDED RELEASE651620810ANDA07838798cc444a-2c39-4410-8020-aded0a8deb81
2332610741ANDAAidarex Pharmaceuticals Llc2009-12-03ALPRAZOLAMORALTABLET, EXTENDED RELEASE651620810ANDA078387f8103235-8cc0-4e81-8fe2-1846f91ce444
3353560503NDA AUTHORIZED GENERICLake Erie Medical Dba Quality Care Products Llc2003-01-17ALPRAZOLAMORALTABLET, EXTENDED RELEASE597620059NDA021434f0bfdd42-caa1-402d-b040-1ac6082ea10a
4458650653ANDAMedsource Pharmaceuticals2011-06-07ALPRAZOLAMORALTABLET, EXTENDED RELEASE658620455ANDA0908711b68bd67-65cf-4c64-e054-00144ff8d46c
5529590965ANDAH.J. Harkins Company, Inc.2007-03-28ALPRAZOLAMORALTABLET, EXTENDED RELEASE649800141ANDA0779964f6c075f-e2b7-41fa-82c7-eba85cbe27a3
6545696187ANDAA-S Medication Solutions Llc2011-05-04ALPRAZOLAMORALTABLET, EXTENDED RELEASE003785022ANDA0773912388e93a-ce12-459d-8331-ea75c2101033
7631870445ANDAProficient Rx Lp2011-06-07ALPRAZOLAMORALTABLET, EXTENDED RELEASE658620455ANDA09087134631dbf-f817-484d-8bcf-f8efa07178d7
8687889682ANDAPreferred Pharmaceuticals, Inc.2013-04-22ALPRAZOLAMORALTABLET, EXTENDED RELEASE658620455ANDA0908718c22b4df-a352-4d90-a5c7-ea67ebb64e8f
9687889727ANDAPreferred Pharmaceuticals, Inc.2012-11-15ALPRAZOLAMORALTABLET, EXTENDED RELEASE651620810ANDA078387bdd5c1be-df05-4423-9e27-2b96a1a35c9a

24 hr alprazolam 2 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000090066XanaxNDAPharmacia And Upjohn Company2003-01-17ALPRAZOLAMORALTABLET, EXTENDED RELEASENDA021434aa58fff3-c297-49be-838b-599c32ad9835

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001158333ANDAGlobal Pharmaceuticals2007-05-24ALPRAZOLAMORALTABLET, EXTENDED RELEASEANDA07796850710e43-bb70-4a2c-a95c-803c3302370d
2002283087ANDAActavis Elizabeth Llc2007-02-13ALPRAZOLAMORALTABLET, EXTENDED RELEASEANDA078056a64496be-bf43-4ba9-a4b1-bd632965c1a0
3597620066NDA AUTHORIZED GENERICGreenstone Llc2003-01-17ALPRAZOLAMORALTABLET, EXTENDED RELEASENDA0214341338d1c9-7c75-42ed-95f3-9eb1b6fc51d3
4605052636ANDAApotex Corp2008-11-12ALPRAZOLAMORALTABLET, EXTENDED RELEASEANDA078449b244cda0-27f1-6708-c5df-916e7b53bd99
5647200189ANDACorepharma, Llc2007-03-28ALPRAZOLAMORALTABLET, EXTENDED RELEASEANDA0779964440015d-5a5c-4f2e-8993-13a94035d70a
6651620812ANDAAmneal Pharmaceuticals2009-12-03ALPRAZOLAMORALTABLET, EXTENDED RELEASEANDA078387259387c1-e374-4bc2-9510-5f7f2c60d1a5
7658620456ANDAAurobindo Pharma Limited2011-06-07ALPRAZOLAMORALTABLET, EXTENDED RELEASEANDA090871326fa31a-5420-429b-9f7f-170cb38f64bd

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900588ANDAStat Rx Usa Llc2007-03-28ALPRAZOLAMORALTABLET, EXTENDED RELEASE649800142ANDA077996db1291e9-ba65-4b6b-83fa-6b6187b17f41
2216950604ANDARebel Distributors Corp2009-12-03ALPRAZOLAMORALTABLET, EXTENDED RELEASE651620812ANDA07838798cc444a-2c39-4410-8020-aded0a8deb81
3216950605ANDARebel Distributors Corp2009-12-03ALPRAZOLAMORALTABLET, EXTENDED RELEASE651620813ANDA07838798cc444a-2c39-4410-8020-aded0a8deb81
4353560504NDA AUTHORIZED GENERICLake Erie Medical Dba Quality Care Products Llc2003-01-17ALPRAZOLAMORALTABLET, EXTENDED RELEASE597620066NDA021434feab3ae1-39a3-4195-8ea3-4a381c0bc454

24 hr alprazolam 3 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000090068XanaxNDAPharmacia And Upjohn Company2003-01-17ALPRAZOLAMORALTABLET, EXTENDED RELEASENDA021434aa58fff3-c297-49be-838b-599c32ad9835

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001158344ANDAGlobal Pharmaceuticals2007-05-24ALPRAZOLAMORALTABLET, EXTENDED RELEASEANDA07796850710e43-bb70-4a2c-a95c-803c3302370d
2002283086ANDAActavis Elizabeth Llc2007-02-13ALPRAZOLAMORALTABLET, EXTENDED RELEASEANDA078056a64496be-bf43-4ba9-a4b1-bd632965c1a0
3597620068NDA AUTHORIZED GENERICGreenstone Llc2003-01-17ALPRAZOLAMORALTABLET, EXTENDED RELEASENDA0214341338d1c9-7c75-42ed-95f3-9eb1b6fc51d3
4605052637ANDAApotex Corp2008-11-12ALPRAZOLAMORALTABLET, EXTENDED RELEASEANDA078449b244cda0-27f1-6708-c5df-916e7b53bd99
5647200190ANDACorepharma, Llc2007-03-28ALPRAZOLAMORALTABLET, EXTENDED RELEASEANDA0779964440015d-5a5c-4f2e-8993-13a94035d70a
6651620813ANDAAmneal Pharmaceuticals2009-12-03ALPRAZOLAMORALTABLET, EXTENDED RELEASEANDA078387259387c1-e374-4bc2-9510-5f7f2c60d1a5
7658620457ANDAAurobindo Pharma Limited2011-06-07ALPRAZOLAMORALTABLET, EXTENDED RELEASEANDA090871326fa31a-5420-429b-9f7f-170cb38f64bd

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA077198ALPRAZOLAMACTAVIS LABORATORIES FL INC2010-05-13ANDA077198_001, ANDA077198_002, ANDA077198_003, ANDA077198_004
2ANDA077391ALPRAZOLAMMYLAN PHARMACEUTICALS INC2006-01-26ANDA077391_001, ANDA077391_002, ANDA077391_003, ANDA077391_004
3ANDA077725ALPRAZOLAMANI PHARMACEUTICALS INC2006-07-31ANDA077725_001, ANDA077725_002, ANDA077725_003, ANDA077725_004
4ANDA077777ALPRAZOLAMTrueSANDOZ INC2006-06-30ANDA077777_001, ANDA077777_002, ANDA077777_003, ANDA077777_004
5ANDA077968ALPRAZOLAMIMPAX LABORATORIES INC2007-05-24ANDA077968_001, ANDA077968_002, ANDA077968_003, ANDA077968_004
6ANDA077979ALPRAZOLAMTrueANI PHARMACEUTICALS INC2007-02-28ANDA077979_001, ANDA077979_002, ANDA077979_003, ANDA077979_004
7ANDA077996ALPRAZOLAMCOREPHARMA LLC2007-01-31ANDA077996_001, ANDA077996_002, ANDA077996_003, ANDA077996_004
8ANDA078056ALPRAZOLAMACTAVIS ELIZABETH LLC2007-02-13ANDA078056_001, ANDA078056_002, ANDA078056_003, ANDA078056_004
9ANDA078387ALPRAZOLAMAMNEAL PHARMACEUTICALS NY LLC2008-05-30ANDA078387_001, ANDA078387_002, ANDA078387_003, ANDA078387_004
10ANDA078442ALPRAZOLAMTrueVINTAGE PHARMACEUTICALS2007-10-15ANDA078442_001, ANDA078442_002, ANDA078442_003, ANDA078442_004
11ANDA078449ALPRAZOLAMAPOTEX INC2008-11-12ANDA078449_001, ANDA078449_002, ANDA078449_003
12ANDA078469ALPRAZOLAMANCHEN PHARMACEUTICALS, INC2011-09-29ANDA078469_001, ANDA078469_002, ANDA078469_003, ANDA078469_004
13ANDA078489ALPRAZOLAMHERITAGE PHARMACEUTICALS INC2008-10-17ANDA078489_001, ANDA078489_002, ANDA078489_003, ANDA078489_004
14ANDA090871ALPRAZOLAMAUROBINDO PHARMA USA INC2011-06-07ANDA090871_001, ANDA090871_002, ANDA090871_003, ANDA090871_004
15NDA021434XANAX XRPHARMACIA AND UPJOHN2003-01-17NDA021434_001, NDA021434_002, NDA021434_003, NDA021434_004

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA077198_001RXALPRAZOLAM (0.5MG)ORALTABLET, EXTENDED RELEASEFalseAB2010-05-13ALPRAZOLAM
2ANDA077198_002RXALPRAZOLAM (1MG)ORALTABLET, EXTENDED RELEASEFalseAB2010-05-13ALPRAZOLAM
3ANDA077198_003RXALPRAZOLAM (2MG)ORALTABLET, EXTENDED RELEASEFalseAB2010-05-13ALPRAZOLAM
4ANDA077198_004RXALPRAZOLAM (3MG)ORALTABLET, EXTENDED RELEASEFalseAB2010-05-13ALPRAZOLAM
5ANDA077391_001RXALPRAZOLAM (3MG)ORALTABLET, EXTENDED RELEASEFalseAB2006-01-26ALPRAZOLAM
6ANDA077391_002RXALPRAZOLAM (0.5MG)ORALTABLET, EXTENDED RELEASEFalseAB2006-01-26ALPRAZOLAM
7ANDA077391_003RXALPRAZOLAM (1MG)ORALTABLET, EXTENDED RELEASEFalseAB2006-01-26ALPRAZOLAM
8ANDA077391_004RXALPRAZOLAM (2MG)ORALTABLET, EXTENDED RELEASEFalseAB2006-01-26ALPRAZOLAM
9ANDA077725_001RXALPRAZOLAM (0.5MG)ORALTABLET, EXTENDED RELEASEFalseAB2006-07-31ALPRAZOLAM
10ANDA077725_002RXALPRAZOLAM (1MG)ORALTABLET, EXTENDED RELEASEFalseAB2006-07-31ALPRAZOLAM
11ANDA077725_003RXALPRAZOLAM (3MG)ORALTABLET, EXTENDED RELEASEFalseAB2006-07-31ALPRAZOLAM
12ANDA077725_004RXALPRAZOLAM (2MG)ORALTABLET, EXTENDED RELEASEFalseAB2006-07-31ALPRAZOLAM
13ANDA077777_001discontinuedALPRAZOLAM (0.5MG)ORALTABLET, EXTENDED RELEASEFalse2006-06-30ALPRAZOLAM
14ANDA077777_002discontinuedALPRAZOLAM (1MG)ORALTABLET, EXTENDED RELEASEFalse2006-06-30ALPRAZOLAM
15ANDA077777_003discontinuedALPRAZOLAM (2MG)ORALTABLET, EXTENDED RELEASEFalse2006-06-30ALPRAZOLAM
16ANDA077777_004discontinuedALPRAZOLAM (3MG)ORALTABLET, EXTENDED RELEASEFalse2006-06-30ALPRAZOLAM
17ANDA077968_001RXALPRAZOLAM (3MG)ORALTABLET, EXTENDED RELEASEFalseAB2007-05-24ALPRAZOLAM
18ANDA077968_002RXALPRAZOLAM (2MG)ORALTABLET, EXTENDED RELEASEFalseAB2007-05-24ALPRAZOLAM
19ANDA077968_003RXALPRAZOLAM (1MG)ORALTABLET, EXTENDED RELEASEFalseAB2007-05-24ALPRAZOLAM
20ANDA077968_004RXALPRAZOLAM (0.5MG)ORALTABLET, EXTENDED RELEASEFalseAB2007-05-24ALPRAZOLAM
21ANDA077979_001discontinuedALPRAZOLAM (0.5MG)ORALTABLET, EXTENDED RELEASEFalse2007-02-28ALPRAZOLAM
22ANDA077979_002discontinuedALPRAZOLAM (1MG)ORALTABLET, EXTENDED RELEASEFalse2007-02-28ALPRAZOLAM
23ANDA077979_003discontinuedALPRAZOLAM (2MG)ORALTABLET, EXTENDED RELEASEFalse2007-02-28ALPRAZOLAM
24ANDA077979_004discontinuedALPRAZOLAM (3MG)ORALTABLET, EXTENDED RELEASEFalse2007-02-28ALPRAZOLAM
25ANDA077996_001RXALPRAZOLAM (0.5MG)ORALTABLET, EXTENDED RELEASEFalseAB2007-01-31ALPRAZOLAM
26ANDA077996_002RXALPRAZOLAM (1MG)ORALTABLET, EXTENDED RELEASEFalseAB2007-01-31ALPRAZOLAM
27ANDA077996_003RXALPRAZOLAM (2MG)ORALTABLET, EXTENDED RELEASEFalseAB2007-01-31ALPRAZOLAM
28ANDA077996_004RXALPRAZOLAM (3MG)ORALTABLET, EXTENDED RELEASEFalseAB2007-01-31ALPRAZOLAM
29ANDA078056_001RXALPRAZOLAM (0.5MG)ORALTABLET, EXTENDED RELEASEFalseAB2007-02-13ALPRAZOLAM
30ANDA078056_002RXALPRAZOLAM (1MG)ORALTABLET, EXTENDED RELEASEFalseAB2007-02-13ALPRAZOLAM
31ANDA078056_003RXALPRAZOLAM (2MG)ORALTABLET, EXTENDED RELEASEFalseAB2007-02-13ALPRAZOLAM
32ANDA078056_004RXALPRAZOLAM (3MG)ORALTABLET, EXTENDED RELEASEFalseAB2007-02-13ALPRAZOLAM
33ANDA078387_001RXALPRAZOLAM (0.5MG)ORALTABLET, EXTENDED RELEASEFalseAB2008-05-30ALPRAZOLAM
34ANDA078387_002RXALPRAZOLAM (1MG)ORALTABLET, EXTENDED RELEASEFalseAB2008-05-30ALPRAZOLAM
35ANDA078387_003RXALPRAZOLAM (2MG)ORALTABLET, EXTENDED RELEASEFalseAB2008-05-30ALPRAZOLAM
36ANDA078387_004RXALPRAZOLAM (3MG)ORALTABLET, EXTENDED RELEASEFalseAB2008-05-30ALPRAZOLAM
37ANDA078442_001discontinuedALPRAZOLAM (0.5MG)ORALTABLET, EXTENDED RELEASEFalse2007-10-15ALPRAZOLAM
38ANDA078442_002discontinuedALPRAZOLAM (1MG)ORALTABLET, EXTENDED RELEASEFalse2007-10-15ALPRAZOLAM
39ANDA078442_003discontinuedALPRAZOLAM (2MG)ORALTABLET, EXTENDED RELEASEFalse2007-10-15ALPRAZOLAM
40ANDA078442_004discontinuedALPRAZOLAM (3MG)ORALTABLET, EXTENDED RELEASEFalse2007-10-15ALPRAZOLAM
41ANDA078449_001RXALPRAZOLAM (0.5MG)ORALTABLET, EXTENDED RELEASEFalseAB2008-11-12ALPRAZOLAM
42ANDA078449_002RXALPRAZOLAM (2MG)ORALTABLET, EXTENDED RELEASEFalseAB2008-11-12ALPRAZOLAM
43ANDA078449_003RXALPRAZOLAM (3MG)ORALTABLET, EXTENDED RELEASEFalseAB2008-11-12ALPRAZOLAM
44ANDA078469_001RXALPRAZOLAM (0.5MG)ORALTABLET, EXTENDED RELEASEFalseAB2011-09-29ALPRAZOLAM
45ANDA078469_002RXALPRAZOLAM (1MG)ORALTABLET, EXTENDED RELEASEFalseAB2011-09-29ALPRAZOLAM
46ANDA078469_003RXALPRAZOLAM (2MG)ORALTABLET, EXTENDED RELEASEFalseAB2011-09-29ALPRAZOLAM
47ANDA078469_004RXALPRAZOLAM (3MG)ORALTABLET, EXTENDED RELEASEFalseAB2011-09-29ALPRAZOLAM
48ANDA078489_001RXALPRAZOLAM (0.5MG)ORALTABLET, EXTENDED RELEASEFalseAB2008-10-17ALPRAZOLAM
49ANDA078489_002RXALPRAZOLAM (1MG)ORALTABLET, EXTENDED RELEASEFalseAB2008-10-17ALPRAZOLAM
50ANDA078489_003RXALPRAZOLAM (2MG)ORALTABLET, EXTENDED RELEASEFalseAB2008-10-17ALPRAZOLAM
51ANDA078489_004RXALPRAZOLAM (3MG)ORALTABLET, EXTENDED RELEASEFalseAB2008-10-17ALPRAZOLAM
52ANDA090871_001RXALPRAZOLAM (0.5MG)ORALTABLET, EXTENDED RELEASEFalseAB2011-06-07ALPRAZOLAM
53ANDA090871_002RXALPRAZOLAM (1MG)ORALTABLET, EXTENDED RELEASEFalseAB2011-06-07ALPRAZOLAM
54ANDA090871_003RXALPRAZOLAM (2MG)ORALTABLET, EXTENDED RELEASEFalseAB2011-06-07ALPRAZOLAM
55ANDA090871_004RXALPRAZOLAM (3MG)ORALTABLET, EXTENDED RELEASEFalseAB2011-06-07ALPRAZOLAM
56NDA021434_001RXALPRAZOLAM (0.5MG)ORALTABLET, EXTENDED RELEASEFalseAB2003-01-17XANAX XR
57NDA021434_002RXALPRAZOLAM (1MG)ORALTABLET, EXTENDED RELEASEFalseAB2003-01-17XANAX XR
58NDA021434_003RXALPRAZOLAM (2MG)ORALTABLET, EXTENDED RELEASEFalseAB2003-01-17XANAX XR
59NDA021434_004RXALPRAZOLAM (3MG)ORALTABLET, EXTENDED RELEASETrueAB2003-01-17XANAX XR

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11338d1c9-7c75-42ed-95f3-9eb1b6fc51d3 (view SPL)Alprazolam XR CIV(alprazolam)extended-release tabletsprescriptionHuman PrescriptionGreenstone LlcANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2014-04-159597620057, 597620059, 597620066, 597620068
21b68bd67-65cf-4c64-e054-00144ff8d46c (view SPL)Alprazolam Extended-Release Tablets USP CIV Rx onlyprescriptionHuman PrescriptionMedsource Pharmaceuticalsrepack2015-07-212458650653
32388e93a-ce12-459d-8331-ea75c2101033 (view SPL)prescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2013-04-291545696187
4259387c1-e374-4bc2-9510-5f7f2c60d1a5 (view SPL)Alprazolam Extended-Release TabletsprescriptionHuman PrescriptionAmneal PharmaceuticalsANALYSIS, LABEL, MANUFACTURE, PACK, REPACK2012-09-106651620809, 651620810, 651620812, 651620813
531dacbaf-4245-4172-9da4-514be309f341 (view SPL)prescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2014-03-271631870337
6326fa31a-5420-429b-9f7f-170cb38f64bd (view SPL)Alprazolam Extended-Release Tablets USP CIVRx onlyprescriptionHuman PrescriptionAurobindo Pharma LimitedANALYSIS, MANUFACTURE2013-12-116658620454, 658620455, 658620456, 658620457
73292a8ff-0664-c0a4-42a6-9827ddb93665 (view SPL)Alprazolam Extended-Release Tablets CIVprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2012-10-122636294061
834631dbf-f817-484d-8bcf-f8efa07178d7 (view SPL)Alprazolam Extended-Release Tablets USP CIV Rx onlyprescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2015-02-011631870445
94440015d-5a5c-4f2e-8993-13a94035d70a (view SPL)Alprazolam Extended-Release Tablets CIV 0.5 mg, 1 mg, 2 mg and 3 mg Rx onlyprescriptionHuman PrescriptionCorepharma, LlcANALYSIS, LABEL, MANUFACTURE, PACK2012-02-132647200187, 647200188, 647200189, 647200190
104f6c075f-e2b7-41fa-82c7-eba85cbe27a3 (view SPL)Alprazolam Extended-Release Tablets CIV0.5 mg, 1 mg, 2 mg and 3 mg Rx onlyprescriptionHuman PrescriptionH.J. Harkins Company, Inc.manufacture2011-12-132529590965
1150710e43-bb70-4a2c-a95c-803c3302370d (view SPL)Alprazolam Extended-Release Tablets,0.5 mg, 1 mg, 2 mg, and 3 mgCIVprescriptionHuman PrescriptionGlobal PharmaceuticalsMANUFACTURE, REPACK2010-06-142001158311, 001158322, 001158333, 001158344
125c921bf0-0a5a-4408-a3d7-b02f907aa321 (view SPL)Alprazolam Extended-Release Tablets CIV 0.5 mg, 1 mg, 2 mg and 3 mg Rx onlyprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2012-10-123636291541
1379114030-6131-4516-9657-a74058dfb87a (view SPL)Alprazolam XR CIV(alprazolam)extended-release tabletsprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrelabel2015-03-021557000109
147e96bc50-4985-4c19-8be9-4f4cf7184c64 (view SPL)ALPRAZOLAM EXTENDED-RELEASE TABLETS, USPprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-07-071000636295364
158c22b4df-a352-4d90-a5c7-ea67ebb64e8f (view SPL)Alprazolam Extended-Release Tablets USP CIV Rx onlyprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2014-06-172687889682
16969acb29-3b5c-47ed-8f7d-a960a24e72e3 (view SPL)Alprazolam Extended-Release Tablets USP CIVRx onlyprescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2015-02-011631870518
1798cc444a-2c39-4410-8020-aded0a8deb81 (view SPL)Alprazolam Extended-Release TabletsprescriptionHuman PrescriptionRebel Distributors Corprelabel, repack2009-12-031216950602, 216950603, 216950604, 216950605
18a64496be-bf43-4ba9-a4b1-bd632965c1a0 (view SPL)ALPRAZOLAM EXTENDED-RELEASE TABLETS, USPprescriptionHuman PrescriptionActavis Elizabeth LlcANALYSIS, MANUFACTURE, PACK2012-09-244002283083, 002283084, 002283086, 002283087
19aa58fff3-c297-49be-838b-599c32ad9835 (view SPL)XANAX XR CIV (alprazolam) extended-release tabletsprescriptionHuman PrescriptionPharmacia And Upjohn CompanyANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2013-10-017000090057, 000090059, 000090066, 000090068
20b244cda0-27f1-6708-c5df-916e7b53bd99 (view SPL)ALPRAZOLAM EXTENDED-RELEASE TABLETS, USPCIV 0.5 mg, 1 mg, 2 mg and 3 mg Rx OnlyprescriptionHuman PrescriptionApotex Corpanalysis, manufacture2013-06-243605052634, 605052635, 605052636, 605052637
21bdd5c1be-df05-4423-9e27-2b96a1a35c9a (view SPL)Alprazolam Extended-Release TabletsprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2014-06-173687889727
22d6cbcdd1-ef4e-487f-83a5-176789b449f5 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2012-02-274003785021, 003785022
23db1291e9-ba65-4b6b-83fa-6b6187b17f41 (view SPL)Alprazolam Extended-Release Tablets CIV0.5 mg, 1 mg, 2 mg and 3 mg Rx onlyprescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2010-03-251165900588
24f0bfdd42-caa1-402d-b040-1ac6082ea10a (view SPL)Alprazolam XR CIV(alprazolam)extended-release tabletsprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrelabel2012-11-161353560503
25f8103235-8cc0-4e81-8fe2-1846f91ce444 (view SPL)Alprazolam Extended-Release TabletsprescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2012-09-102332610741
26feab3ae1-39a3-4195-8ea3-4a381c0bc454 (view SPL)Alprazolam XR CIV(alprazolam)extended-release tabletsprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2012-05-213801353560504

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII